An implantable activity detector can detect metabolic stress levels, which can be normalized, such as to identify times of activities such as walking and running or to identify trends such as a decrease in metabolic activity. The data can be derived from different sources such as an accelerometer and pedometer. This data can be compared to independently specifiable thresholds, such as to trigger an alert or responsive therapy, or to display one or more trends. The information can also be combined with other congestive heart failure (CHF) indications. The alert can notify the patient or a caregiver, such as via remote monitoring. metabolic activity data from one or more of the activity detectors can be used to establish a model of metabolic stress, to which further activity data can be compared for identifying periods of increased or decreased metabolic stress.
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15. A method comprising:
detecting a physical movement by a subject within a time period using an activity detector;
measuring exertion data using the activity detector, the exertion data indicating an exertion level of the subject using the detected physical movement by the subject within the period;
determining a metabolic stress indicator using a processor circuit, the metabolic stress indicator derived from an indication of an integration or area under the curve of the exertion data over the period; and
generating an alert, using an alert response module, in response to the metabolic stress indicator meeting a specified criterion.
1. A system comprising:
an activity detector, configured to:
detect a physical movement by a subject; and
measure exertion data, indicating an exertion level of the subject, measured from the detected physical movement by the subject;
a processor circuit, coupled to the activity detector, the processor configured to analyze the exertion data from the activity detector, the processor configured to determine a metabolic stress indicator derived from an integration or area under the curve calculation of the measured exertion data occurring during the exertion within a time period; and
an alert response module operatively coupled to the processor circuit, the alert response module configured to generate an alert in response to the metabolic stress indicator meeting a specified criterion.
2. The system of
3. The system of
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8. The system of
9. The system of
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12. The system of
detect the physical movement by the subject; and
provide an accelerometer output signal indicating the physical movement by the subject.
13. The system of
14. The system of
16. The method of
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This patent document pertains generally to patient monitoring and more particularly, but not by way of limitation, to monitoring metabolic energy consumption.
Patient monitoring can be used for various needs, such as to determine therapy efficacy. Through both long term and short term assessment of patient metabolic energy consumption, physical activity can be correlated with an indication of patient condition or prognosis.
An implantable or external activity sensor (e.g., accelerometer) can be used to detect patient activity. A daily average metabolic equivalent (MET) can be calculated from the activity sensor output. Trending daily average METs may provide useful information related to a patient well-being. Without being bound by theory, the present inventors believe that integrating activity sensor output data over a twenty-four hour period can provide better predictive value than certain other approaches, such as measuring a time duration that patient activity exceeds a fixed activity threshold. The information from the activity sensor can be converted into units such as METs, which represents O2 consumption and can be directly related to calories burned. Storing or logging activity sensor output data over a twenty-four hour period permits determining a daily average MET for a subject. Trending the daily average METs can help the patient or caregiver in determining whether patient condition has changed. For example, an increased severity of chronic heart failure (CHF) can correlate to reduced O2 consumption. This can be detected as reduced metabolic activity, such as a decrease in the daily average METs. The daily average METs can be compared to a threshold value and used to generate an alert to notify the patient or a caregiver, such as via remote monitoring. The daily average METs patient status indication can be combined with one or more other patient status indications, such as from one or more additional physiological sensors (e.g., respiration, heart rate, weight, etc.), such as to provide a more complete indication of patient well-being.
Example 1 describes a system comprising an activity detector and a processor circuit, coupled to the activity detector. The activity detector is configured to detect physical activity indication of a subject. The processor is configured to analyze exertion data from the activity detector and the processor is configured to determine a metabolic stress indicator derived from an integration or area under the curve calculation of the measured exertion data occurring during the physical activity within a time period.
In Example 2, the system of Example 1 is optionally configured with the processor providing a normalized average metabolic equivalent indication to a user or automated process.
In Example 3, the system of at least one of Examples 1-2 optionally includes a trending module, operatively coupled to the activity detector and processor circuit. The trending module is configured to trend normalized average metabolic equivalent indication occurring two or more times within a specified duration.
In Example 4, the system of at least one of Examples 1-3 is optionally configured with the activity detector configured to detect a period of sustained physical activity exceeding a specified exertion level and a specified duration.
In Example 5, the system of at least one of Examples 1-4 is optionally configured with the specified exertion level comprising at least 20 mGs.
In Example 6, the system of at least one of Examples 1-5 is optionally configured with the specified duration comprising at least three minutes.
In Example 7, the system of at least one of Examples 1-6 is optionally configured with the activity detector configured to determine a total number of steps per day.
In Example 8, the system of at least one of Examples 1-7 is optionally configured with the activity detector configured to determine a daily average MET using measured exertion data wherein the exertion data is obtained in increments of less than one minute.
In Example 9, the system of at least one of Examples 1-8 optionally includes an alert module, operatively coupled to the activity detector and processor circuit. The alert module is configured to generate an alert indication in response to a change in value of at least one of the exertion data or the normalized average metabolic equivalent indication, wherein the change in value occurs at least once within a specified time duration.
In Example 10, the system of at least one of Example 1-9 optionally configured with the specified time duration comprising at least two days.
Example 11 includes a method comprising detecting physical activity of a subject within a time period, computing exertion data using the detected physical activity within the period, and determining a metabolic stress indicator derived from an indication of an integration or area under the curve of the exertion data over the period.
In Example 12, the method of Example 11 optionally includes providing a normalized average metabolic equivalent indication to a user or process.
In Example 13, the method of at least one of Examples 11-12 is optionally includes trending the normalized average metabolic equivalent indication.
In Example 14, the method of at least one of Examples 11-13 is optionally performed such that detecting physical activity comprises detecting a period of sustained physical activity exceeding a specified exertion level and a specified duration.
In Example 15, the method of at least one of Examples 11-14 is optionally performed such that the specified exertion level comprises at least 20 mGs.
In Example 16, the method of at least one of Examples 11-15 is optionally performed such that the specified duration comprises at least three minutes.
In Example 17, the method of at least one of Examples 11-16 optionally includes determining a step rate derived from an averaged acceleration measurement of the subject movement over the period.
In Example 18, the method of at least one of Examples 11-17 optionally includes deriving a metabolic equivalent (MET) from an acceleration within the period.
In Example 19, the method of at least one of Examples 11-18 is optionally performed such that determining a metabolic stress indicator comprises deriving a step total energy derived from the detected physical activity within the period.
In Example 20, the method of at least one of Examples 11-19 optionally includes measuring at least one physiological parameter during the detected physical activity of the subject, wherein the measured physiological parameter varies with physical activity of the subject, and reporting the physiological parameter measurement to a user or automated process.
In Example 21, the method of at least one of Examples 11-20 is optionally performed such that providing a normalized average metabolic equivalent indication comprises deriving a number representative of average metabolic equivalent (MET) over the period.
In Example 22, the method of at least one of Examples 11-21 optionally includes generating an alert in response to a change in value of at least one of the exertion data or the normalized average metabolic equivalent indication, wherein the change in value occurs at least once within a specified time duration.
In Example 23, the method of at least one of Examples 11-22 is optionally performed such that the specified time duration comprises at least two days.
In Example 24, the method of at least one of Examples 11-23 is optionally performed such that determining a metabolic stress indicator comprises deriving a value representative of a population.
In Example 25, the method of at least one of Examples 11-24 is optionally performed such that determining a metabolic stress indicator comprises deriving a value representative of the subject.
Example 26 describes a system comprising means for detecting physical activity of a subject within a time period, means for computing exertion data using the detected physical activity within the period, and means for determining a metabolic stress indicator derived from an indication of an integration or area under the curve calculation of the measured exertion data over the period.
In Example 27, the system of Example 26 optionally includes means for providing a normalized average metabolic equivalent indication to a user or automated process.
In Example 28, the system of at least one of Examples 26-27 optionally includes means for computing exertion data. The means for computing exertion data comprises applying one or more of a metabolic equivalent (MET) or a step rate obtained from an acceleration measurement of the subject movement.
In the drawings, which are not necessarily drawn to scale, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document.
In this example, the implantable device 102 can include a hermetically sealed housing to carry electronics, and can include a general activity detector 110, such as a step counter 112, a processor 113, a clock 114, an alert response module 116 and a therapy controller 118. In the example of
In the example of
The information obtained from either the general activity detector 110 or step counter 112 can be used to calculate physiological stress and converted into units more easily understood by those in the medical community, such as METs. In certain examples, the general activity detector 110 can output accelerometer-derived exertion data, which can be expressed in “milliG” or “mG” (where 1 G represents the acceleration of gravity, and 1 mG represents 1/1000 of 1 G). An example of a simulation of such data is represented in the graph of
MET=0.026*mG+1.5 (1)
In order to determine an overall metabolic stress over a monitored period of time, statistical analysis can be performed on the exertion data from a general activity detector, such as that obtained from an accelerometer or step counter, occurring within a given time period using an area under the curve (AUC) analysis. For example, overall metabolic stress over a monitored period of time can be obtained by multiplying an average METs by the monitored period of time (t), or by integrating a trended indication of METs over the monitored period of time. In certain examples, the step counter 112 can provide data representing total steps over a period or stepping rate (e.g., steps per day). This information can assist the user or caregiver in determining whether the subject's physical activity (e.g., walking) has decreased, which can indicate increased severity of a patient's CHF condition. Using the exertion data from a general activity detector 110 (expressed in mGs), the number of equivalent steps from a step counter 112 can be determined using Equation (2):
Steps=1.274*AUC−133 (2)
In certain examples, a time-normalized average METs value can be derived by dividing the AUC values by the time period used in the calculations. This value can provide the user or caregiver a daily value with which to monitor metabolic activity of the subject. In certain examples, both total steps and general accelerometer-derived exertion level can be analyzed over the same time period. This allows correlation between the two activity data sources to be ascertained. For example, if an increased generalized accelerometer-derived exertion at 10:30 in the morning occurred at the same time when step activity increased for a period of ½ hour, it can be inferred that the subject took a morning walk for half an hour. In certain examples, METs can be derived from the measured number of steps over a given period of time (t) using Equation (3):
It may be useful to establish a baseline for a subject, so that the METs value can be compared to a lower bound (e.g., a resting value) and an upper bound (e.g., a maximum value attainable by the subject). In order to establish an upper bound for a subject, one possible expression for physiological metabolic response is “VO2max,” which refers to a maximum rate of oxygen consumption. VO2max represents the maximum amount of oxygen, in milliliters (ml), that the subject can use in one minute, expressed per kilogram (kg) of body weight. The VO2max for a given subject can be determined using a treadmill or step test in which the subject performs a timed physical test and the weight of the subject is obtained. This number can be converted to METs to represent the maximum metabolic expenditure of the patient. A lower bound can be established by measuring the resting VO2, representing a minimum metabolic expenditure (usually close to 1 MET). The upper and lower bounds can be used to establish a VO2 range, which can be converted into a METs range using Equation (4):
The METs for a given time (t) can then be compared or viewed with respect to the subject metabolic range to determine where a given daily average fits within that subject's range and further to identify trends in average MET from day to day or month to month.
Additionally, with the incorporation of weight of the subject (in kg), as determined in the VO2 max. determination, the physiological scale of kCals can be determined. KCals represents the energy needed to increase the temperature of 1 kg of water by 1° C., which is one thousand calories. The user or physician may wish to express the physical activity of the subject in kCals using Equation (5):
kCal=r*VO2*kg (5)
The term r represents a conversion factor comprising a range of 4.8 to 5.0. The term kg in Equation (5) represents the subject's weight expressed in kilograms, which may be used from historical data or provided to the implantable device 102 via communication module 103, after weighing the subject.
Variations on this technique are also possible. For example, at 602, the increment value can be specified by the user or caregiver in increments of approximately one second, to days, weeks or months. Another approach would be to compare the exertion level to a threshold value, and to monitor the number of times the threshold value is reached, or the length of time spent at an exertion level that is above the value. However, the AUC method provides considerably more detailed information about the exertion and its associated time frame. For example, the AUC method allows one to identify not only how long a particular activity level occurred, but at what time it occurred in relation to other activity levels, and to detect a period of sustained physical activity exceeding a specified exertion level during a specified duration. In certain examples, the general activity detector 110 can detect physical activity by the subject but either the exertion level is very low (e.g., below 20 mGs) or the activity lasts for a very short time (e.g., 2 minutes or less). During such times, in certain examples, the exertion measured by the general activity detector 110 or step counter 112 can be identified as occurring during a rest state.
Although the above description has emphasized an example in which processing is generally carried out within an implantable device, information derived from the respiration signal obtained from the implantable device can be communicated to external local interface 104 or external remote server 106 to perform such processing at such other locations. Moreover, such processing can include information from one or more devices that are not implanted. For example, a body weight measurement, as measured by an external weight scale, could be combined with a general activity detector obtained from an implantable cardiac function management device, e.g., during processing at external remote server 106, to generate a CHF wellness indicator or to trigger an alert or responsive therapy.
In certain examples, information from the processor 113 (e.g., indications of sudden onset of increased or decreased activity levels) can be provided to the communication module 103, and communicated to the external local interface 104 or the external remote server 106, such as for storage or for display on a monitor, for example, as separate trends of metabolic daily averages derived from step counts or exertion data, or as histograms of normalized daily average METs, or in any other useful form.
The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls.
In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B,” includes “A but not B.” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects.
Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code may form portions of computer program products. Further, the code may be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times. These computer-readable media may include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAM's), read only memories (ROM's), and the like.
The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.
Carlson, Gerrard M., Wariar, Ramesh, Beck, Kenneth, Kawahara, Chie
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